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Denali Therapeutics plans to submit a BLA early next year that will seek accelerated approval for DNL310 (tividenofusp alfa) and i...[ Price : $8.95]
FDA releases a guidance entitled Bioresearch Monitoring Technical Conformance Guide Technical Specifications Document that provid...[ Price : $8.95]
FDA releases the form FDA-483 with five observations from an inspection at the Otsuka Pharmaceutical second factory in Tokushima, ...[ Price : $8.95]
FDA clears an Embecta 510(k) for its Disposable Patch Pump for Insulin Delivery, intended for use by adults who require insulin to...[ Price : $8.95]
Federal Register notice: FDA classifies certain digital therapy devices for attention deficit hyperactivity disorder into Class 2.[ Price : $8.95]
Federal Register notice: FDA classifies neuromuscular tongue muscle stimulators and their use for reducing snoring and obstructive...[ Price : $8.95]
CDER and CBER seek input to help advance the agencys model-informed drug development program.[ Price : $8.95]
FDA grants an emergency use authorization for an updated version of Novavaxs Covid-19 vaccine that more closely targets currently ...